October, 2023

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Finding a Collaborative, Data-Driven Future for Pharma

MedCity News

The future of pharmaceutical innovation hinges on enhanced data discovery and collaboration. Through data sharing and collective effort, the pharmaceutical industry can accelerate the development of new therapies.

Pharma 125
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UPDATED: Pfizer plans to shutter New Jersey site, discloses layoffs amid $3.5B cost-cutting drive

Fierce Pharma

Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.

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Actor and epilepsy advocate Greg Grunberg wants the world to ‘talk about it’

PharmaVoice

The actor of “Heroes” and “Star Wars: The Force Awakens” fame is starring in another role as a patient advocate for people with epilepsy.

Patients 138
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LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”

Pharmaceutical Commerce

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Life Sciences Innovation Day – Accelerating Digital Transformation Ambition

European Pharmaceutical Review

Schneider Electric, a leader in digital transformation, energy management and automation, has announced the speaker lineup for its exclusive event, Life Sciences Innovation Day – Accelerating Digital Transformation Ambition. Set at the world-renowned Silverstone F1 Racetrack on 18 October 2023, it promises to be a day of immersive insights and top rate networking.

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The PM360 Trailblazer Awards 2023 Winners

PM360

PM360 has announced the winners of its 15 th annual Trailblazer Awards. Established in 2009, the Trailblazer Awards recognize and honor outstanding companies, marketers, marketing teams, brand managers, and initiatives that have demonstrated innovation and achieved incredible results in the life sciences. In total, PM360 recognized 73 winners across eight overall categories: Companies of the Year, CEOs of the Year, Products of the Year, Marketer of the Year, Marketing Team of the Year, Lifetime

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With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

Fierce Pharma

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.

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Patient groups have become a powerhouse in R&D. Here’s a look at their impact.

PharmaVoice

“They have the money,” and they’re using it to influence drug development, according to the executive director of the IQVIA Institute for Human Data Science.

Patients 128
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An Evolving ‘Opinion’ Landscape: New Paths—and Synergies—for Pharma KOLs & DOLs

PharmExec

Industry experts discuss the relationship between digital and traditional (key) opinion leaders and how companies are adjusting their strategies to harness the unique brand engagement benefits each role can provide in driving better patient outcomes.

Pharma 119
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First-in-class phosphate absorption inhibitor approved by FDA

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Ardelyx’s first-in-class oral treatment is indicated to reduce serum phosphorus in adults with chronic kidney disease ( CKD ) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant to phosphate binder therapy.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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CCC Releases AI-Enabled Affiliation Matching Software Powering Open Access Publication Modeling and Analysis for Publishers

Copyright Clearance Center

October 10, 2023 – Danvers, Mass. – CCC , the leading provider of Open Access (OA) workflow solutions, announces new data import capabilities and AI-enabled affiliation matching in its OA Agreement Intelligence modeling and analytics tool that provides publishers with a 360-degree view of disambiguated publication data to build accurate, transparent institutional offers regarding OA.

Training 119
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FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

MedCity News

The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.

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Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Fierce Pharma

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.

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The FDA might yank cold medicines from shelves — and that could be just the beginning

PharmaVoice

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

FDA 119
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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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3 Ways AI is Already Changing Advertising (and None Are Generative AI)

PM360

Everyone’s buzzing about generative artificial intelligence (AI), and it’s true that technology like ChatGPT is already having an enormous impact on advertising and marketing. But other AI tools that our industry has been using for years have changed the face of media planning and buying. The examples below share how we have been utilizing AI for our pharma clients.

Media 115
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Europe’s pharmaceutical packaging market to value over $35bn by 2028

European Pharmaceutical Review

Europe’s pharmaceutical packaging and labelling market is projected to reach $35.78 billion in 2028, according to a report by Arizton. Having been valued at $27.04 billion in 2022, the pharmaceutical packaging and labelling market in Europe is expected to expand at a compound annual growth rate (CAGR) of 4.78 percent up to 2028. Europe’s position in the global pharmaceutical packaging and labelling market The authors highlighted that Europe led the worldwide market at 27 percent in 2022.

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CCC to Host Virtual Town Hall on AI, Licensing, and the Path Forward

Copyright Clearance Center

October 3, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing and leading information solutions provider to organizations around the world, will host a Town Hall via LinkedIn Live on “AI, Licensing, and the Path Forward” on Thursday, 12 October, 10:00 EDT/15:00 BST/16:00 CEST. CCC’s Vice President, General Counsel Catherine Zaller Rowland and a panel of legal experts including Prof.

Training 119
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Is Medicare Advantage a Failed Experiment? Experts Debate

MedCity News

Enrollment in Medicare Advantage is increasing, but the program has been drawing scrutiny from the government. Can the program be saved? One expert believes Medicare Advantage is a failed experiment. Another thinks that while the program has its flaws, it shows tremendous potential.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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As COVID sales crater, Pfizer takes $5.6B in inventory write-offs on Paxlovid, Comirnaty

Fierce Pharma

For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials. | Pfizer's pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.

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Hyloris wins painkiller approval amidst amplified anti-opioid efforts

Pharmaceutical Technology

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

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Multilocation Healthcare Marketing: Minimum Daily Requirements

Healthcare Success

Do you want to compete in each of your local markets? Do you want to position your healthcare products and services where your target audience actively seeks them? If so, you need a custom digital marketing strategy and budget for each location. We like to call this budget the “minimum daily requirement.” Why is this so important? Unless you have a solid local strategy, your business will not show up online where and when it matters most.

Marketing 112
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Starvation stress key in Micrococcus luteus cleanroom survival

European Pharmaceutical Review

A paper by Tim Sandle, Head of Microbiology, Risk Management and Sterility Assurance at Bio Products Laboratory Ltd has underlined the importance of proper cleanroom disinfection practices by elucidating on the robust survival mechanism of the bacterium Micrococcus luteus (M. luteus). As “one of the most abundant organisms on the outer layer of human skin” M. luteus is a common contaminant recovered from cleanrooms, according to Sandle.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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CCC Hosts Annual ‘We Not Me’ Global Volunteering Event

Copyright Clearance Center

Oct. 31, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing and leading information solutions provider, held its annual ‘We Not Me’ global volunteering event as part of a year-round charity initiative about demonstrating the power of individual action to build community and support the common good. CCC US-based staff collaborated with colleagues in various parts of the country including Massachusetts, New Hampshire, Rhode Island, Oregon, Washington, and California, serving

Education 115
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How Digital Technologies are Solving Pain Points for Pharma Companies

MedCity News

AI technologies have a role in the life sciences that goes beyond drug discovery. A panel at the MedCity News INVEST conference in Dallas discussed how new tech platforms help speed up the process of recruiting patients and running clinical trials.

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PhRMA, industry players urge Supreme Court to overturn abortion pill restrictions

Fierce Pharma

If there’s one thing a wide swath of industry players can agree on, it’s that the FDA’s drug approval process represents the gold standard for drug regulation. | Influential trade group PhRMA—plus hundreds of drugmakers, leaders and investors—are urging the Supreme Court to overturn a restrictive ruling on the abortion pill mifepristone. In SCOTUS filings, the industry representatives said the ruling undermines the FDA's authority.

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FDA Creates Advisory Committee on Digital Health Technologies

PharmaTech

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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The ALS therapy keeping the human pig heart transplant pumping

PharmaVoice

Eledon’s investigational ALS drug tegoprubart could also help prevent organ transplant rejections, the company says.

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Are we globally prepared for the next pandemic?

European Pharmaceutical Review

Echoes of the global health challenges we faced during the COVID-19 pandemic still linger as new variants emerge and COVID continues to make headlines. A question that continues to sit in the back of many people’s minds is what happens if there is another outbreak or global pandemic? Are we preparing and how ready are we for the next one? Vaccitech’s Chief Business Officer, Graham Griffiths, discusses key learnings in drug and vaccine development , the challenges of preparing for the unknown, an

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ADDF announces speech database to identify biomarkers for Alzheimer’s

Pharmaceutical Technology

SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.

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These 10 Trends Are Affecting The Healthcare Economy The Most

MedCity News

Healthcare-focused market research firm Trilliant Health published a report detailing the 10 most significant economic trends affecting U.S. healthcare stakeholders in 2023. Some of the main ideas covered in the report included Americans’ worsening physical and mental health, the industry’s shift away from traditional care pathways, and the way patients’ decision making is becoming increasingly driven by consumerism.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.